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Shire receives FDA approval for INTUNIV extended release tablets

Shire plc, the global specialty biopharmaceutical company, today announced that it has received approval from the US Food and Drug Administration (FDA) for INTUNIV(TM) (guanfacine) Extended Release Tablets for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in children and adolescents aged 6 to 17 years.

4 Sep 2009

Takeda receives FDA response regarding NDA for fixed-dose combination of alogliptin and ACTOS

Takeda Pharmaceutical Company Limited ("Takeda") today announced that its wholly owned subsidiary, Takeda Global Research & Development Center, Inc. (U.S.), received on September 2 (U.S. TIME), a complete response letter from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for the fixed-dose combination (FDC) of alogliptin and ACTOS(R) (pioglitazone HCl).

4 Sep 2009

OSI Pharmaceuticals initiates two clinical trials with OSI-906 oral insulin-like growth factor-1 receptor inhibitor

OSI Pharmaceuticals, Inc. (NASDAQ: OSIP) announced today the initiation of two clinical trials with OSI-906, the Company’s potential first-in-class, oral insulin-like growth factor-1 receptor (IGF-1R) inhibitor. The first study is a Phase III, multi-center study that will evaluate the use of OSI-906 for patients with locally advanced or metastatic adrenocortical carcinoma (ACC).

4 Sep 2009

Dr Lluis Quintana-Murci from the Institut Pasteur in France honoured with the Debiopharm Life Sciences Award

Debiopharm Group, SA (Debiopharm), a Swiss-based global biopharmaceutical group of companies with a focus on the development of prescription drugs that target unmet medical needs, today presented the 'Debiopharm Life Sciences Award' to Dr Lluis Quintana-Murci from the Institut Pasteur in France, for his outstanding innovative research in the emerging field of evolutionary genetics of infection.

4 Sep 2009

$NEI awards grant to Vivakor for developing a digital photo-refractor$

NEI awards grant to Vivakor for developing a digital photo-refractor

Vivakor, Inc. announced that the National Institutes of Health-National Eye Institute has awarded a grant to Vivakor, Inc. in Coralville, IA through the Small Business Innovation Research Awards.

4 Sep 2009

Phase III clinical trial results of XIAFLEX published in a journal

BioSpecifics Technologies Corp., a biopharmaceutical company developing first in class collagenase-based products today announced results of the pivotal CORD I Phase III clinical trial of XIAFLEX (collagenase clostridium histolyticum), a novel, first-in-class biologic for the nonsurgical treatment of Dupuytren's disease, was published in today's edition of the New England Journal of Medicine.

4 Sep 2009

White House 'rallies the faithful' for health overhaul push

The White House is going beyond the Wednesday speech to take control of the health reform debate, including a road trip to urge passage of legislation.

4 Sep 2009

nSpire Health awarded over $9 million for clinical research trials

nSpire Health, a leading global manufacturer of respiratory diagnostic products and services, announced today clinical trial research services awards of over $9 million in August. The trials awarded by prominent pharmaceutical companies include the company’s eSP™ core lab services, gold standard KoKo® spirometry, and new patent pending PiKoLogic® electronic patient reported outcomes (ePRO) solution.

4 Sep 2009

HTDS announces closure of Regulation D 504 offering

Hard to Treat Diseases (the "Company") (HTDS.PK) announced today that it has closed its Regulation D, Rule 504 offering and is no longer selling shares of its common stock to accredited investors.

4 Sep 2009

Pzifer to pay $2.3 billion in medicare/medicaid fraud settlement

The Obama administration announced a landmark $2.3 billion health care fraud settlement with Pfizer, Inc. Wednesday, which is expected to change drug companies' promotion of off-label use of medicines.

4 Sep 2009

Shire's INTUNIV (Guanfacine) approved by the FDA for treatment of Attention-Deficit/Hyperactivity Disorder

Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, today announced that it has received approval from the US Food and Drug Administration (FDA) for INTUNIV- (guanfacine) Extended Release Tablets for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in children and adolescents aged 6 to 17 years. INTUNIV, a once-daily formulation of guanfacine, is the first selective alpha-2A adrenergic receptor agonist approved for the treatment of ADHD.

4 Sep 2009

Lawsuits filed against Johnson & Johnson, Ortho-McNeil Pharmaceutical and Walgreen

St. Louis-based law firm Carey & Danis LLC announces the filing of four civil lawsuits on behalf of twenty plaintiffs against Johnson & Johnson (NYSE: JNJ) and Ortho-McNeil Pharmaceutical Inc., the makers of the powerful antibiotic Levaquin, as well as the Walgreen Co. (NYSE:WAG), which sells the drug.

4 Sep 2009

Sodium chloride for treating head lice

At just 31 years of age, and with a first grader in tow, single mom Wendy Langley set out to take on the giants in the head lice industry. The reason? She couldn't, as she says, stand putting a popular but potentially toxic head lice treatment that "smelled like bug spray" on her kid's head to kill lice. Plus, she was constantly terrified the runny liquid would seep into her daughter's eyes.

4 Sep 2009

Acticoat Flex dressings with NUCRYST's SILCRYST nanocrystalline silver coatings launched in Europe

NUCRYST Pharmaceuticals, a developer and manufacturer of medical products that fight infection and the Advanced Wound Management division of Smith Nephew plc announced today the European launch of Acticoat(TM) Flex3 and Acticoat(TM) Flex7. The Flex range is the newest addition to the Acticoat(TM) portfolio of dressings with NUCRYST's proprietary SILCRYST(TM) nanocrystalline silver coatings.

4 Sep 2009

SFDA approves production license for Sinovac's H1N1 vaccine

Sinovac Biotech Ltd. (NYSE: SVA), a leading provider of biopharmaceutical products in China, announced today that the State Food and Drug Administration (SFDA) has approved the registration application for PANFLU.1, Sinovac's H1N1 vaccine, and has issued Sinovac a production license for this vaccine.

4 Sep 2009

ERT celebrates a significant milestone: Completes 150Th QT clinical Trial

ERT (Nasdaq: ERES) has celebrated a significant milestone by completing its 150th thorough QT clinical Trial (TET). ERT provides full TET support to the biopharmaceutical industry, including consultation, study design, and provision of ECG equipment to ECG analysis, data processing, management, reconciliation, reporting, quality control and regulatory support.

4 Sep 2009

Acurox's New Drug Application discussed with the FDA

Acura Pharmaceuticals, Inc. and King Pharmaceuticals, Inc. announced today that they met with the U.S. Food and Drug Administration ("FDA") on September 2, 2009 to discuss the FDA’s June 30, 2009 Complete Response Letter regarding the New Drug Application for Acurox (oxycodone HCl and niacin) Tablets CII (NDA).

4 Sep 2009

IND for Cytopia's CYT387 clears the FDA review

Cytopia Limited's Investigational New Drug Application (IND) for CYT387 has passed US Food and Drug Administration (FDA) review. CYT387 is a small-molecule oral JAK1/JAK2 kinase inhibitor designed to treat various haematological disorders.

4 Sep 2009

Brown University neuroscience professor awarded EUREKA grant

Brown University neuroscience professor Gilad Barnea will receive a nearly $1.3 million, four-year federal grant toward development of a method to selectively monitor the activation of each of the five receptors for the neurotransmitter dopamine in the brain.

4 Sep 2009

Two ongoing Phase 2 clinical trials of CPX-351 to be showcased

Celator Pharmaceuticals today announced that Scott Jackson, chief executive officer, is scheduled to present at the Thomas Weisel Partners 2009 Healthcare Conference in Boston.

4 Sep 2009